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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 25 - Otober 9, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
1995

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Testing carried out prior to OECD guidelines. The acute oral toxicity of the test substance was studied in groups fasted male and female rats of Winstar at a dosage of 2000 mg per kg. The test material was administered on Day 0. Mortality and signs of reaction to treatment were recorded during a 14-day period of observation.
GLP compliance:
not specified
Test type:
other: Single dose method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction Mass of (1S,2R,5R)-2-(2-hydroxypropan-2-yl)-5-methylcyclohexan-1-ol and (1R,2R,5R)-2-(2-hydroxypropan-2-yl)-5-methylcyclohexan-1-ol
Molecular formula:
not applicable
IUPAC Name:
Reaction Mass of (1S,2R,5R)-2-(2-hydroxypropan-2-yl)-5-methylcyclohexan-1-ol and (1R,2R,5R)-2-(2-hydroxypropan-2-yl)-5-methylcyclohexan-1-ol
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age: 45 day old
- Weight at study initiation: males: 202 to 221g, females: 155 to 170g.
- Fasting period before study:
- Housing: polycarbonate cages with stainless steel grid tops
- Diet: ad libitum except on the day of dosing
- Water: ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25°C +/- 3°C
- Humidity (%): 50% +/-10%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle per day

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
gavage
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
The acute oral toxicity of p-Menthan-3,8-diol was studied in groups fasted male and female rats of Winstar at a dosage of 2000 mg per kg. The test material was administered on Day 0. Mortality and signs of reaction to treatment were recorded during a 14-day period of observation.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none observed
Clinical signs:
other: none obeserved
Gross pathology:
none observed
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the acute oral approximate lethal dosage (LD50) was:
male: more than 2000 mg/kg
female: more than 2000 mg/kg
Combined sexes: more than 2000 mg/kg
Therefore, the test substance can be classifed as relatively harmless.